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Идёт набор NCT04107285

Looking at Cognitive and Brain Changes in People With Lymphoma Receiving CAR-T Therapy

— Наблюдательное Lymphoma Receiving CAR-T Therapy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: neurocognitive evaluations, brain MRIs, Blood samples.
Кому может быть актуально
Состояния в реестре: Lymphoma Receiving CAR-T Therapy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Study of Longitudinal Neurocognitive and Neuroimaging Evaluations for Adult Patients With Lymphoma Receiving CD19 CAR T Cell Therapy

Обзор

The purpose of this study is to learn about possible changes in cognitive (mental) abilities, such as memory skills and concentration, and in brain anatomy (structure) and function, in people with lymphoma receiving CAR-T therapy.

Вмешательства

  • Поведенческое neurocognitive evaluations
    The test battery consists of validated and reliable measures of attention, executive functions and memory.
  • Диагностический тест brain MRIs
    Patients will undergo baseline and follow-up research MRIs in the same scanner at MSKCC (3 Tesla scanner (GE, Discovery 750W, USA) with a GEM HNU 24-channel head coil) (total scan duration=15 minutes).
  • Другое Blood samples
    Research blood samples will be collected pre-CAR T infusion; day of CART infusion (day 0), and post-infusion days 7, 14, 21, 28 (+/- 7 days), at start of neurotoxicity, and at 3-4 months and 6-7 months post-CART.

Первичные конечные точки

  • changes in neurocognitive functions [Срок оценки: 1 year]
  • changes in functional connectivity [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Patients must be 18 years of age or older
  • Planned treatment with commercial CD19-specific CAR T cells (axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel, or brexacabtagene autoleucel) for lymphoma.
  • Patients must have adequate end organ function for CAR T cell therapy
  • Eastern Cooperative Group (ECOG) performance status of 0 to 2
  • Meet cardiac, pulmonary, hematologic, hepatic, and renal requirements for CART therapy as described in corresponding product package insert
  • No evidence of central nervous system disease at study entry
  • Fluent and able to communicate well enough in English to complete the study assessments and provide informed consent, in the judgment of the consenting professional. o Patients who report that English is not their primary language will be asked the US Census English proficiency question: "How well do you speak English," and the answer "very well" will be required

Критерии исключения

  • Signs and/or symptoms of central nervous system cancer (e.g., metastases, leptomeningeal disease) as determined by their physician, medical records, or by a brain MRI, either at the time of enrollment or during the study period.
  • Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report
  • History of neurodegenerative disease, or traumatic brain injury with loss of consciousness (>60 minutes), as per medical records or patient report
  • A history of epilepsy as per medical records or patient report
  • Current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report
  • Evidence of visual or auditory impairment that would preclude completion of the assessments, as per medical records or patient report
  • Contraindications to MRI examinations as per standard screening guidelines used in the Department of Radiology (i.e., ferromagnetic material or implants, pacemakers or defibrillators, stents, claustrophobia)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Memorial Sloan Kettering Cancer Center — New York

Идентификаторы

NCT: NCT04107285 · 19-268

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗